Journal of Gastric Cancer

The Korean Gastric Cancer Association (대한위암학회)
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Efficacy and Safety of ClearCutTM Knife H-type in Endoscopic Submucosal Dissection for Gastric Neoplasms: A Multicenter, Randomized Trial

  • Eun Jeong Gong (Department of Internal Medicine, Hallym University College of Medicine) ;
  • Hyun Lim (Division of Gastroenterology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine) ;
  • Sang Jin Lee (Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine) ;
  • Do Hoon Kim (Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine)
  • Received : 2023.01.30
  • Accepted : 2023.04.19
  • Published : 2023.07.31
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Abstract

Purpose: Endoscopic submucosal dissection (ESD) is an effective treatment for early gastrointestinal neoplasms. However, this is a time-consuming procedure requiring various devices. This study aimed to evaluate the efficacy and safety of the ClearCutTM Knife H-type, which is an integrated needle-tipped and insulated-tipped (IT) knife. Materials and Methods: Between July 2020 and September 2021, 99 patients with gastric epithelial neoplasms scheduled for ESD at three tertiary care hospitals were randomly assigned to H-knife (ClearCutTM Knife H-type) or IT-knife (conventional IT knife) groups. Procedure times, therapeutic outcomes, and adverse events were analyzed. Results: A total of 98 patients (50 in the H-knife group and 48 in the IT-knife group) were analyzed. The median total procedure time was 11.9 minutes (range, 4.4-47.2 minutes) in the H-knife group and 12.7 minutes (range, 5.2-137.7 minutes) in the IT-knife group (P=0.209). Unlike the IT-knife group, which required additional devices in all cases, no additional devices were used in the H-knife group (P<0.001). En-bloc resection was performed for all lesions in both groups. The incidence of adverse events was not significantly different between groups (4.0% in the H-knife group vs. 8.3% in the IT-knife group; P=0.431). Conclusions: The newly developed hybrid device, the ClearCutTM Knife H-type, had comparable efficacy to the conventional IT knife for gastric ESD.

Keywords

Acknowledgement

This work was supported by 'Supporting Project to Evaluation New Domestic Medical Devices in Hospitals' funded by the Ministry of Health and Welfare (MOHW) and the Korea Health Industry Development Institute (KHIDI).

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